An Early Phase 1 interventional study of remimazolam besylate and propofol in Anesthesia, sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-12-05.
Sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital · Early Phase 1, Interventional, and Treatment
The evidence on the practice of remimazolam besylate during cardiac anesthesia is scarce. This study investigates the efficacy and safety of remimazolam besylate general induction and maintenance during cardiac surgery.
Remimazolam besylate (RB), as a new benzodiazepine sedative agent, has been approved in clinical anesthesia with prominent characteristics of short onset/offset, less depression for cardiovascular or respiratory function and specific antagonist. Some studies have confirmed the comparable anesthesia efficacy of remimazolam for outpatient digestive endoscopy, fiberoptic bronchoscopy, facial plastic and orthopedic surgery as propofol. Currently, the evidence on its application in cardiac anesthesia is insufficient. Our study aims to evaluate the efficacy of remimazolam besylate and propofol and provide an ideal anesthetic agent to achieve the goal of early recovery after cardiac surgery.
Chinese Academy of Medical Sciences, Fuwai Hospital is the lead sponsor of 146 studies on the registry; 50 are open to participants now.
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Patients received an initial dose of remimazolam (0.3mg/kg) for induction and a continuous infusion rate of 1 mg/kg/h for anesthesia maintenance.
Drug: remimazolam besylate
Patients received an initial dose of propofol (1.0 mg/kg) and a continuous infusion rate of 1-1.5 mg/kg/h
Drug: propofol
Patients received an initial dose of remimazolam (0.3mg/kg) for induction and a continuous infusion rate of 1 mg/kg/h for anesthesia maintenance. Sedative was adjusted to maintain a bispectral index (BIS) at 40-60 after induction.
Patients received an initial dose of propofol (1.0 mg/kg) and a continuous infusion rate of 1-1.5 mg/kg/h. Sedative was adjusted to maintain a bispectral index (BIS) at 40-60 after induction.
ratio of successful sedation during the whole surgery
Sedation success is defined as BIS locating in the range of 40-60 according to the required dosage without additional rescue sedative during the surgical procedures.
Time frame: Intraoperative period
time interval for BIS from baseline before induction to 60
Time frame: Intraoperative period
No study locations are listed for this record.
Plan to share: No
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This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Remimazolam besilate
Chinese Academy of Medical Sciences, Fuwai Hospital →